WHITE HOUSE TO BAR NIH FROM POLICING ITSELF

John Crewdson, Chicago TribuneCHICAGO TRIBUNE

The Bush administration is expected to announce this week a major reorganization of the government`s machinery for investigating fraud in scientific research, according to sources familiar with the plan.

The move will strip the National Institutes of Health, the government`s biomedical research agency, of all responsibility for investigating what the NIH terms ''scientific misconduct'' by researchers, including its own.

Sources said the NIH`s Office of Scientific Integrity, which currently has that authority, would be replaced by a new agency within the Department of Health and Human Services. The new agency will be named the Office of Research Integrity.

One NIH source said a principal reason for the abolition of the OSI was to ''lessen the likelihood that NIH is seen as an agency investigating itself.''

Sources said the Office of Research Integrity will be headed on an interim basis by Dr. J. Michael McGinnis, currently deputy assistant HHS secretary for health. The current OSI director, Dr. Jules Hallum, will reportto McGinnis, the sources said.

Apart from the elimination of NIH`s role, the most significant aspect ofthe reorganization entails providing scientists accused of misconduct with the opportunity to have their cases heard in a quasi-judicial setting.

In its three years of existence, the OSI has investigated more than 100 cases of alleged misconduct, both by NIH researchers and by university scientists who receive NIH funding. The agency is perhaps best known, however, for its 2-year investigation of the early AIDS research of the prominent NIH scientist, Dr. Robert Gallo.

Although not yet approved by senior HHS officials, the final report in the Gallo case has engendered considerable criticism from Congress and elsewhere.

Rep. John Dingell, the Michigan Democrat whose subcommittee on investigations oversees NIH, charged last month that the Gallo report, which he described as having been ''seriously watered down,'' raised ''serious questions'' about whether NIH ''can objectively investigate and take action against prominent scientists.''

A panel of consultants drawn from the National Academy of Sciences also criticized the OSI for failing to present its findings in ''a larger context, namely a pattern of behavior on Dr. Gallo`s part that repeatedly misrepresents, suppresses and distorts data and their interpretation in such away as to enhance Dr. Gallo`s claim to priority and primacy.''

Under the new plan, NIH Director Bernadine Healy, who ordered some of the controversial changes in the Gallo report, would play no role in the investigation or adjudication of cases of alleged scientific misconduct. A proposal to create a new Research Integrity Policy Board that would have been headed by the NIH director has been scrapped, sources said.

''Investigating folks is not NIH`s bag,'' one NIH source said. ''This just doesn`t set well with the scientific constituency that NIH has to workwith 365 days a year.''

Under the existing system, the OSI both investigated allegations ofmisconduct and reached conclusions as to the guilt or innocence of those underinvestigation. The new plan will keep separate the investigative andadjudicative functions and provide scientists accused of misconduct with the right to a hearing at which they and their attorneys can examine the evidence against them, cross-examine their accusers and present rebuttal witnesses.

Such hearings would be chaired by members of the HHS Board of Appeals, who currently perform the function of administrative judges.

A question not explicitly addressed by the plan is the fate of cases, like the Gallo investigation, that are still in the HHS ''pipeline'' but whose targets did not enjoy the new due-process protections.

Although the OSI criticized Gallo`s ''disregard for accepted standards of professional and scientific ethics,'' he was found not guilty of formal misconduct after the OSI concluded he had not known that some of the data in one of his landmark scientific articles was falsified.

The responsibility for those falsifications was attributed by OSI to Gallo`s former chief virologist, Dr. Mikulas Popovic, who was found guilty of misconduct. That finding has not yet been approved by HHS officials, however, and Popovic`s lawyer, Barbara Mishkin, said she would ''welcome the opportunity to have a proper hearing'' for her client.

Yet to be resolved is the question of what, precisely, constitutes

''scientific misconduct.'' The current definition adopted by the Public Health Service covers fabrication, falsification and plagiarism, plus other practices ''that seriously deviate from those that are commonly accepted within the scientific community.''

That language became an issue in the Gallo case when the three university scientists who formed OSI`s panel of expert advisers voted 2-1 against invoking the broader definition against Gallo. A Public Health Service advisory committee later recommended that the broader definition be removed from the official description of misconduct. Sources said that recommendation was still under review.